Associate Regulatory Affairs Labeling Associate

Job Description

Our Regulatory Affairs team brings essential generic quality medicines to U.S. patients by providing Regulatory leadership and establishing regulatory systems and processes that support Civica’s mission.

The Associate, Regulatory Affairs Labeling and Artwork (remote position):

·       Supports all aspects of product labeling and artwork development, review, approval, implementation and maintenance for Civica’s private label distribution (PLD) products.

·       Follow labeling and artwork procedures that comply with FDA, GMP, ISO and other applicable standards and regulations.

·       Coordinates and prepares Office of Prescription Drug Promotion (OPDP) submissions as needed.

·       Works within systems to maintain labeling and artwork.

·       Owns or impact assesses change controls for PLD labeling impact.

Responsibilities Include:

·       Coordinate labeling and artwork design by an external vendor

·       Collaborate with the supply chain, contract manufacturers, packagers, and external vendors to ensure timely implementation of approved labeling changes.

·       Maintain labeling and artwork records within applicable electronic systems and document repositories.

·       Support preparation and submission of Office of Prescription Drug Promotion (OPDP) materials, as needed.

·       Maintain FDA drug listings information and associated regulatory records.

·       Participate in change control activities as a change owner, contributor, or impact assessor, as appropriate, to evaluate and implement labeling-related changes.

·       Review labeling components and artwork for accuracy, consistency, completeness, and compliance with approved regulatory content.

·       Ensure labeling information included in regulatory submissions is complete, accurate, and consistent.

·       Support continuous improvement initiatives related to labeling processes, systems, and workflows.

·       Perform any other tasks/duties as assigned by management.

What we look for:

We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest for our patients.

Technical Skills;

Proven experience in critically reviewing documents for consistency and accuracy. Excellent proofreading/editing skills are required.

Strong organizational skills.

Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strives to continuously improve and build knowledge and skills.

Teamwork:

Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust.

Quality Management:

Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

Education Minimum Requirement :

Bachelor’s degree required, focus in Life Sciences preferred.

Required Experience and Skills :

At least one to two 2+ years of relevant experience within the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and/or artwork development or promotional review.

Physical demands of the position include only those required for work in a typical office environment. Minimal travel (0-5%) may be necessary in the execution of the listed duties